Human ADME Study of [14C]-AZD1390

NCT07643870 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: D6940C00006
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief Summary

This is a Phase I, multicentre, single-dose, open-label study to assess the absorption, distribution, metabolism, and excretion of \[14C\]-AZD1390.

Conditions

Advanced Solid Malignancies

Keywords

AZD1390; Malignancies; Solid tumor; Glioblastoma; Radioactivity / radiation; Metabolite / metabolism; ATM kinase inhibitor; Pharmacokinetics; Single-dose; ADME

Outcome Measures

Primary Outcomes (38)

• The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

  Amount excreted (Ae) (urine)

  6 Weeks

• The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

  Cumulative Amount excreted (CumAe) (urine)

  6 Weeks

• The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

  Amount excreted (Ae) (feaces)

  6 Weeks

• The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

  Cumulative Amount excreted (CumAe) (feaces)

  6 Weeks

• The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

  Amount excreted (Ae) (total - urine and feaces combined)

  6 Weeks

• The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

  Cumulative Amount excreted (CumAe) (total urine and feaces combined)

  6 Weeks

• The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

  Amount (percentage) excreted (Fe) (urine)

  6 Weeks

• The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

  Cumulative Amount (percentage) excreted (CumFe) (urine)

  6 Weeks

• The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

  Amount (percentage) excreted (Fe) (feaces)

  6 Weeks

• The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

  Cumulative Amount (percentage) excreted (CumAe) (feaces)

  6 Weeks

• The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

  Amount (percentage) excreted (Fe) (total urine and faeces combined)

  6 Weeks

• The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

  Cumulative Amount (percentage) excreted (CumFe) (total urine and faeces combined)

  6 Weeks

• The mass balance of total Radioactivity of AZD1390 and its metabolites after a single oral dose

  If emesis occurs, vomitus will be analysed for total radioactivity

  6 Weeks

• Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

  Analysis of plasma: Maximum observed concentration (Cmax)

  6 weeks

• Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

  Analysis whole blood: Maximum observed concentration (Cmax)

  6 weeks

• Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

  Analysis of plasma: Area under the concentration-time curve from zero to infinity (AUCinf)

  6 weeks

• Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

  Analysis of whole blood: Area under the concentration-time curve from zero to infinity (AUCinf)

  6 weeks

• Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

  Analysis of plasma: Area under the concentration-time curve from zero to the last measurable concentration (AUClast)

  6 weeks

• Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

  Analysis of whole blood: Area under the concentration-time curve from zero to the last measurable concentration (AUClast)

  6 weeks

• Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

  Analysis of plasma: Time to reach maximum observed plasma concentration (Tmax)

  6 weeks

• Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

  Analysis of whole blood: Time to reach maximum observed plasma concentration (Tmax)

  6 weeks

• Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

  Analysis of plasma: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz )

  6 weeks

• Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

  Analysis of whole blood: Half-life associated with terminal slope (λz) of a semi-logarithmic concentration-time curve (t1/2λz )

  6 weeks

• Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

  Analysis of plasma: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)

  6 weeks

• Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

  Analysis of whole blood: Apparent total body clearance of drug from plasma after extravascular administration (CL/F)

  6 weeks

• Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

  Analysis of plasma: Mean residence time of the unchanged drug in the systemic circulation (MRT)

  6 weeks

• Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

  Analysis of whole blood: Mean residence time of the unchanged drug in the systemic circulation (MRT)

  6 weeks

• Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

  Analysis of plasma: Apparent volume of distribution at steady state following extravascular administration (Vss/F)

  6 weeks

• Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

  Analysis of whole blood: Apparent volume of distribution at steady state following extravascular administration (Vss/F)

  6 weeks

• Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

  Analysis of plasma: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)

  6 weeks

• Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

  Analysis of whole blood: Apparent volume of distribution during the terminal phase after extravascular administration (Vz/F)

  6 weeks

• Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

  Ratio of AUCinf of plasma AZD1390 relative to AUCinf of plasma total radioactivity

  6 weeks

• Pharmacokinetic(s) of AZD1390 and the distribution of total radioactivity into blood cells after a single oral dose

  Ratio of AUCinf of whole blood total radioactivity to AUCinf of plasma total radioactivity

  6 weeks

• Pharmacokinetic(s) of AZD1390 after a single oral dose

  Analysis of urine: Cumulative amount excreted (CumAe)

  6 weeks

• Pharmacokinetic(s) of AZD1390 after a single oral dose

  Analysis of urine: Fraction (percentage) excreted (Fe)

  6 weeks

• The distribution of total radioactivity into blood cells after a single oral dose

  Analysis of urine: Fraction (percentage) excreted (Fe)

  6 weeks

• Pharmacokinetic(s) of AZD1390 after a single oral dose

  Analysis of urine: Cumulative fraction (percentage) excreted (CumFe)

  6 weeks

• Pharmacokinetic(s) of AZD1390 after a single oral dose

  Analysis of urine: Renal clearance (CLR)

  6 weeks

Secondary Outcomes (16)

• The phamrmacokinetic(s) of AZD1390 metabolite

  6 weeks

• The phamrmacokinetic(s) of AZD1390 metabolite

  6 weeks

• The phamrmacokinetic(s) of AZD1390 metabolite

  6 weeks

• The phamrmacokinetic(s) of AZD1390 metabolite

  6 weeks

• The phamrmacokinetic(s) of AZD1390 metabolite

  6 weeks

Study Arms (1)

AZD1390

EXPERIMENTAL

Single dose of \[14C\]-AZD1390

Drug: AZD1390

Interventions

AZD1390 DRUG

single dose

AZD1390

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with Histologically or cytologically documented, locally advanced or metastatic solid tumour, excluding lymphoma, no active anticancer treatment,
• ECOG performance status of 0 or 1 with no deterioration over the 2 weeks,
• Predicted life expectancy ≥ 12 weeks,
• Adequate organ and marrow function,
• Creatinine clearance ≥ 50 mL/min,
• Regular bowel movements,
• No cancer-associated cachexia (weight loss).

You may not qualify if:

• History or presence of myopathy or raised CK \> 5 × ULN at screening,
• History of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment,
• History or presence of clinically significant hepatic disease,
• History of epileptic disorder or any seizure history unrelated to tumour,
• History of MDS/AML or with features suggestive of MDS/AML,
• Predisposition to bleeding
• History of persisting (\> 2 weeks) severe cytopenia
• Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection
• History of another primary malignancy
• Persistent toxicities (CTCAE Grade ≥ 2), excluding alopecia, caused by previous anticancer therapy,
• Spinal cord compression or brain metastases for at least 4 weeks

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (2)

Research Site

Guildford, GU2 7WG, United Kingdom

Location

Research Site

Liverpool, L7 8XP, United Kingdom

Location

MeSH Terms

Conditions

Neoplasms; Glioblastoma

Interventions

AZD1390

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open label

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: June 12, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): April 12, 2028
• Study Completion (Estimated): April 12, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

GB (2)